What is SAE?
SAE definition and meaning on Health terms:
An adverse event is any undesirable experience associated with the use of a medicine in a patient. An adverse event is described as a serious adverse event and must be reported when a patient dies or suffers a life-threatening event, if they have to be hospitalised (or remain in hospital for longer), or if they are left with a substantial disability or birth defect. Other events such as those requiring emergency intervention to prevent one of the serious outcomes described above might also be reported as a serious adverse event.